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临床试验/NCT04295343
NCT04295343已完成不适用

Three-dimensional Rectal Water Contrast Transvaginal Ultrasonography Versus Computed Colonography in the Diagnosis of Rectosigmoid Endometriosis

Ospedale Policlinico San Martino1 个研究点 分布在 1 个国家目标入组 68 人开始时间: 2017年3月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
68
试验地点
1
主要终点
To compare the accuracy of 3D-RWC-TVS and CTC in the diagnosis of rectosigmoid endometriosis.

研究概览

简要总结

Rectosigmoid involvement by endometriosis causes intestinal symptoms such as constipation, diarrhea, and dyschezia. A non-invasive diagnosis of bowel endometriosis is relevant to provide the patients information on the potential hormonal or surgical treatments. The objective of the current study was to compare the performance of three-dimensional rectal water contrast transvaginal ultrasonography (3D-RWC-TVS) and computed colonography (CTC) in predicting the presence and characteristics of rectosigmoid endometriosis.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • pain and intestinal symptoms suggestive of rectosigmoid endometriosis

排除标准

  • previous surgical diagnosis of intestinal endometriosis
  • previous radiological diagnosis of intestinal endometriosis (based on Magnetic Resonance or double-contrast barium enema
  • history of colorectal surgery (except appendectomy)
  • contraindications to bowel preparation or computed colonography (such as non-- compliant patients and rectal malformations)
  • previous bilateral ovariectomy
  • psychiatric disorders

结局指标

主要结局

To compare the accuracy of 3D-RWC-TVS and CTC in the diagnosis of rectosigmoid endometriosis.

时间窗: At maximum 6 months before laparoscopic surgical approach

The results of imaging will be compared with surgical and histological findings.

次要结局

  • To compare the precision of 3D-RWC-TVS and CTC in estimating the length (mid-sagittal diameter) of the rectosigmoid endometriotic nodules(At maximum 6 months before laparoscopic surgical approach)
  • To compare the accuracy of 3D-RWC-TVS and CTC in the diagnosis of multifocal rectosigmoid endometriosis.(At maximum 6 months before laparoscopic surgical approach)
  • To compare the precision of 3D-RWC-TVS and CTC in estimating and the distance between the lower margin of the rectosigmoid endometriotic nodules and the anal verge(At maximum 6 months before laparoscopic surgical approach)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Fabio Barra

Principal Investigator

Ospedale Policlinico San Martino

研究点 (1)

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